Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction

NCT04317911 | Completed

• 1 other identifier: UKHD-2-520/2015
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) displays high prevalence in heart failure with preserved ejection fraction (HF-PEF) and compromises prognosis of affected patients. This study aims to assess catheter ablation (CA) for AF in patients with HF-PEF compared to AF-patients without systolic or diastolic dysfunction. Primary endpoints are freedom from AF and quality of life at 1 year. Furthermore, the study is designed to elucidate mechanistic characteristics distinguishing arrhythmic substrate and predicting AF-recurrence in patients with HF-PEF. For this purpose, left atrial concentrations of biomarkers for inflammation, fibrosis and neurohumoral activation are determined and hemodynamic measurements are performed periprocedurally. Information on benefit from CA in these patients is necessary for clinical decision making and mechanistic investigations may point to tailored approaches in order to increase therapeutic efficiency.

Conditions

Atrial Fibrillation

Keywords

Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• Arrhythmia recurrence

  Clinical arrhythmia and holter-recording

  12 months

Secondary Outcomes (8)

• nTproBNP

  12 months

• Troponin T

  12 months

• Systolic left ventricular function in echocardiography

  12 months

• Diastolic left ventricular function in echocardiography

  12 months

• PA-pressure in echocardiography

  12 months

Interventions

Catheter Ablation OTHER

Patients with preserved ejection fraction presenting for catheter ablation via of atrial fibrillation are included in this study and prospectively observed regarding arrhythmia-related, functional and biomarker-associated outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for evaluation for CA of AF with a left ventricular systolic ejection fraction ≥50% are identified and invited to undergo further stratification. All patients are submitted to thorough clinical screening for signs and symptoms of heart failure, echocardiographic assessment of diastolic function and blood test for peripheral plasma levels of natriuretic peptides. Based on these parameters, patients with heart failure with preserved ejection fraction (HF-PEF) are identified according to current guidelines. Patients not meeting HF-PEF-criteria are included in the control group. Their data and follow-up results are gathered in a registry from which age- and gender-matched controls are extracted for comparison with respective matched HF-PEF-cases.

You may qualify if:

• Left ventricular ejection fraction ≥50%
• Scheduled for catheter ablation of AF

You may not qualify if:

• Significant valvular heart disease
• Coronary artery disease with \>70% stenoses or necessary coronary Intervention at time of recruitment
• Coronary intervention 60 days before recruitment
• Coronary bypass surgery 90 days before recruitment
• Cardiomyopathy or cardiac storage disease (e.g. amyloidosis)
• Reduced left ventricular ejection fraction
• Pericardiac disease
• Significant pulmonary hypertension
• Chronic obstructive pulmonary disease with home-oxygen-therapy, oral steroids, hospitalization due to exacerbations during the last 12 months before recruitment, or suspected severe pulmonary condition based on clinical evaluation
• Other non-cardiac conditions associated with limited physical capacity (adipositas permagna, severe anemia)
• Pregnancy
• Other limitations for adequate performance of stress echocardiography (e.g. orthopedic reasons)

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator

Study Sites (1)

University Hospital Heidelberg, Department of Cardiology

Heidelberg, Germany

Location

Related Publications (1)

• Zylla MM, Leiner J, Rahm AK, Hoffmann T, Lugenbiel P, Schweizer P, Scholz E, Mereles D, Kronsteiner D, Kieser M, Katus HA, Frey N, Thomas D. Catheter Ablation of Atrial Fibrillation in Patients With Heart Failure and Preserved Ejection Fraction. Circ Heart Fail. 2022 Sep;15(9):e009281. doi: 10.1161/CIRCHEARTFAILURE.121.009281. Epub 2022 Jun 21.

  PMID: 36126143 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Maura M Zylla, Dr. med.

  University Hospital Heidelberg, Department of Cardiology (Prof. Dr. H.A. Katus)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 23, 2020
• Study Start: January 26, 2016
• Primary Completion: September 1, 2021
• Study Completion: February 1, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)